{"id":"ultracet-tablets","safety":{"commonSideEffects":[{"rate":"25-33%","effect":"Dizziness"},{"rate":"15-24%","effect":"Nausea"},{"rate":"10-15%","effect":"Constipation"},{"rate":"10-13%","effect":"Headache"},{"rate":"10-13%","effect":"Somnolence"},{"rate":"8-10%","effect":"Pruritus"},{"rate":"5-10%","effect":"Vomiting"}]},"_chembl":{"chemblId":"CHEMBL942","moleculeType":"Small molecule","molecularWeight":"361.40"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tramadol acts as a weak mu-opioid receptor agonist and inhibits the reuptake of norepinephrine and serotonin, enhancing descending pain inhibitory pathways. Acetaminophen works through poorly understood mechanisms involving central COX inhibition and endocannabinoid system modulation. 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Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2007-09","conditions":"Rheumatic Diseases","enrollment":982},{"nctId":"NCT01778075","phase":"PHASE1","title":"A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2012-12","conditions":"Healthy","enrollment":56},{"nctId":"NCT01968018","phase":"PHASE4","title":"A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.,Thailand","startDate":"2004-07","conditions":"Cancer","enrollment":35},{"nctId":"NCT00634543","phase":"PHASE4","title":"A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2006-12","conditions":"Diabetic Neuropathy","enrollment":162},{"nctId":"NCT01112267","phase":"PHASE3","title":"An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2009-05","conditions":"Low Back Pain","enrollment":248},{"nctId":"NCT00635349","phase":"PHASE4","title":"A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2007-05","conditions":"Osteoarthritis","enrollment":143},{"nctId":"NCT00766675","phase":"PHASE4","title":"An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Taiwan Ltd","startDate":"2008-10","conditions":"Pain, Fibromyalgia","enrollment":80},{"nctId":"NCT01814878","phase":"PHASE3","title":"A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2009-11","conditions":"Pain, Postoperative","enrollment":320},{"nctId":"NCT00973232","phase":"PHASE1","title":"A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Labopharm Inc.","startDate":"2008-05","conditions":"Healthy","enrollment":58},{"nctId":"NCT00647517","phase":"PHASE4","title":"Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Chung Shan Medical University","startDate":"2008-03","conditions":"Ankylosing Spondylitis","enrollment":60},{"nctId":"NCT01063842","phase":"PHASE4","title":"A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2005-08","conditions":"Osteoarthritis","enrollment":250},{"nctId":"NCT00653315","phase":"PHASE1","title":"Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2002-05","conditions":"To Determine Bioequivalence Under Fasting Conditions","enrollment":28}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1844,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Reference drug"],"phase":"marketed","status":"active","brandName":"Ultracet Tablets","genericName":"Ultracet Tablets","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ultracet combines tramadol (an opioid agonist and monoamine reuptake inhibitor) with acetaminophen to provide analgesia through dual pathways of pain relief. Used for Moderate acute pain in adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}